FDAFDA · Food and drugs·Recall number Z-1371-2026
Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
Published February 25, 2026 · Recall initiated: October 22, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Firm is initiating a removal due to continued reports of adverse events.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.
- Lot
- Model No. TB-0545FCS; UDI: 04953170383533, 04953170383526, 04953170409684, 04953170383519; All Lots.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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